MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETER

Catalog Number CRUS6A

Device Problems Overheating of Device (1437); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Visual inspection and functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation.The definitive root cause for this event could not be determined based upon the available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: warnings and precautions: when using the crosser in tortuous anatomy, the use of a support catheter is recommended to prevent kinking or prolapse of the crosser catheter tip.Kinking or prolapse of the tip could cause catheter breakage and/or malfunction.Adverse events: as with most percutaneous interventions, potential adverse effects include: bleeding which may require transfusion or surgical intervention, hematoma, perforation, dissection, guidewire entrapment and/or fracture, hypertension/hypotension, infection or fever, allergic reaction, pseudoaneurysm or fistula aneurysm, acute reclosure, thrombosis, ischemic events, distal embolization, excessive contrast load resulting in renal insufficiency or failure, excessive exposure to radiation, stroke/cva, restenosis, repeat catheterization / angioplasty, peripheral artery bypass, amputation, death or other bleeding complications at access site.Interventional use: slowly advance the catheter tip through the lesion.Apply steady, constant pressure so the tip of the catheter is engaged to the lesion.Upon successful recanalization of the lesion, advance the guidewire distal to the lesion and then withdraw the crosser s6 from the body and advance a guidewire through the lesion.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that during use in an occlusion beginning at the sfa and extending down to the popliteal, the recanalization catheter had been used for a total of approximately three minutes when during a 30 second activation pause, the hcp moved the recanalization catheter and support sheath further down the occlusion and as the hcp stepped on the foot pedal, a "pop" sound was allegedly heard and the hcps gloved hand became hot.Reportedly, the activation was immediately halted.It was further reported that it was then identified that approximately 1.5cm of the distal tip of the recanalization catheter allegedly became detached and was fully encompassed in the support sheath.Using a syringe, the hcp reportedly then pulled negative pressure and retracted the catheter, distal tip and support sheath together as a single unit without incident.A wire was used to cross the remainder of the occlusion and balloon angioplasty was then completed.The patient was reported to be doing well with good blood flow post procedure.

Manufacturer Narrative

Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Visual/microscopic inspection: the device was returned in segments.The distal end of the catheter was returned detached from the catheter, with 2.0cm of the core wire.A portion of the catheter was detached along with the distal tip.The core wire remaining within the catheter was measured to be 148.9cm.A 2.0cm segment of the core wire was found fractured within the catheter.No signs of melting or overheating were observed along the length of the catheter.The catheter was stretched in appearance at the location of the detachment, indicating excessive force was applied to the catheter.The core wire fracture was examined under microscopic magnification and the fracture appeared to be clean.No other anomalies were noted to the catheter.The support catheter was returned in segments.The sheath appeared to have been cut in half, likely from when the user removed the detached distal tip of the crosser catheter from the usher catheter.The distal tip was returned detached from the catheter, measuring 5.9cm in length.The distal end of the usher support catheter was examined under microscopic magnification and was not flared in appearance.No other anomalies were noted to the catheter.Functional/performance evaluation: no functional testing could be performed due to the catheter detachment.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the device was returned.The investigation was confirmed for a tip detachment and a catheter detachment, as the distal tip was returned detached along with a portion of the catheter.The investigation was confirmed for a core wire fracture, as a segment of the core wire was found fractured within the catheter.The investigation was inconclusive for overheating, as functional testing could not be performed due to the poor sample condition.The definitive root cause for this event could not be determined based upon the available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: warnings and precautions: when using the crosser in tortuous anatomy, the use of a support catheter is recommended to prevent kinking or prolapse of the crosser catheter tip.Kinking or prolapse of the tip could cause catheter breakage and/or malfunction.Adverse events: as with most percutaneous interventions, potential adverse effects include: bleeding which may require transfusion or surgical intervention, hematoma, perforation, dissection, guidewire entrapment and/or fracture, hypertension/hypotension, infection or fever, allergic reaction, pseudoaneurysm or fistula aneurysm, acute reclosure, thrombosis, ischemic events, distal embolization, excessive contrast load resulting in renal insufficiency or failure, excessive exposure to radiation, stroke/cva, restenosis, repeat catheterization / angioplasty, peripheral artery bypass, amputation, death or other bleeding complications at access site.Interventional use: slowly advance the catheter tip through the lesion.Apply steady, constant pressure so the tip of the catheter is engaged to the lesion.Upon successful recanalization of the lesion, advance the guidewire distal to the lesion and then withdraw the crosser s6 from the body and advance a guidewire through the lesion.(b)(4).

Event Description

It was reported that during use in an occlusion beginning at the sfa and extending down to the popliteal, the recanalization catheter had been used for a total of approximately three minutes when during a 30 second activation pause, the hcp moved the recanalization catheter and support sheath further down the occlusion and as the hcp stepped on the foot pedal, a "pop" sound was allegedly heard and the hcps gloved hand became hot.Reportedly, the activation was immediately halted.It was further reported that it was then identified that approximately 1.5cm of the distal tip of the recanalization catheter allegedly became detached and was fully encompassed in the support sheath.Using a syringe, the hcp reportedly then pulled negative pressure and retracted the catheter, distal tip and support sheath together as a single unit without incident.A wire was used to cross the remainder of the occlusion and balloon angioplasty was then completed.The patient was reported to be doing well with good blood flow post procedure.

• Brand Name: CROSSER CTO RECANALIZATION CATHETER
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5747065
• MDR Text Key: 48101101
• Report Number: 2020394-2016-00570
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: CRUS6A
• Device Lot Number: GFAP2139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1