MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G50319

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2023

Event Type  malfunction  

Manufacturer Narrative

E1: customer name and address: street: (b)(6).Line 2: (b)(6).H3: device evaluated by mfg: other (81) - device evaluation has begun.However, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr, part 803.And is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

As reported, during an unspecified procedure.An advance 14 lp low profile balloon catheter leaked.Another manufacturer's 6-french sheath was used during the procedure.The anatomy was not tortuous.But was reportedly, slightly calcified.The balloon catheter was advanced into the diseased, 40% occluded lesion of the posterior tibial/inferior genicular arteries, over an unspecified wire guide.A "special balloon inflation pressure pump" was used during the first attempted inflation of the balloon.However, fluoroscopy found that the balloon could not be inflated.Despite a reduction in contrast agent within the pump.Blood was not noted, in the inflation device and the balloon was not inflated within a stent.The user stopped the attempted inflation, and the balloon was removed over the wire guide.The balloon was then tested outside of the patient, and a pinhole leak was noted, in the balloon.Another balloon was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures, due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects, due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unspecified procedure, an advance 14 lp low profile balloon catheter leaked.Another manufacturer's 6-french sheath was used during the procedure.The anatomy was not tortuous, but was reportedly slightly calcified.The balloon catheter was advanced into the diseased, 40% occluded lesion of the posterior tibial/inferior genicular arteries, over an unspecified wire guide.A "special balloon inflation pressure pump" was used during the first attempted inflation of the balloon; however, fluoroscopy found that the balloon could not be inflated, despite a reduction in contrast agent within the pump.Blood was not noted in the inflation device and the balloon was not inflated within a stent.The user stopped the attempted inflation and the balloon was removed over the wire guide.The balloon was then tested outside of the patient, and a pinhole leak was noted in the balloon.Another balloon was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, drawings, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.A pinhole leak in the balloon material was noted approximately 3.9 centimeters from the distal tip of the catheter.A complaint history search on the complaint lot found no additional complaints reported from the field.The device history record for the complaint lot found no relevant non-conformances.A subassembly lot found two relevant non-conformances, however, all non-conforming product was scrapped.Although these non-conformances are relevant to the reported failure mode, all non-conforming product was scrapped, there are 100% inspections to capture this non-conformance.Adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that non-conforming product exists in house or in field.The product instruction for use (fu) warns ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressure.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information and results of the investigation, cook has concluded that a component failure contributed to this event.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16919496
• MDR Text Key: 315096501
• Report Number: 1820334-2023-00590
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002503196
• UDI-Public: (01)10827002503196(17)250815(10)14897198
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G50319
• Device Catalogue Number: PTAX4-14-170-2-20
• Device Lot Number: 14897198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2022
• 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
• Treatment: APT 6FR SHEATH.
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 50 KG