MAUDE Adverse Event Report: CORDIS DE MEXICO CATH MB 5F PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532598B

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/18/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.  the product was returned for evaluation and testing; however, the engineering evaluation is not complete.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, during a percutaneous transluminal angioplasty (pta)/femoral procedure, the 110 cm.6 fr.Mb pigtail 6sh catheter had broken in two parts: the distal part remained inside the patient but the staff was able to remove it with another device.Now both parts are available for further examination.The customer did not perform any kind of movement that could break in two the catheter and did not modify the device before the procedure.The product will be returned for inspection.There was no reported patient injury.Additional information received indicated that the reported product issue of separation did not particularly occur during withdrawal of the product.There was more reported resistance than usual but no reported withdrawal difficulty or excessive force used during withdrawal.A guidewire was in place during withdrawal of the product as per the instructions for use (ifu).An embolic protection device was used to successfully retrieve the separated portion of the device.There was no reported difficulty advancing the product to the intended location.No target lesion/target lesion characteristic information was available.Another catheter was used to complete the procedure successfully with no patient injury.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu with no problems noted during preparation.There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.No additional information is available.

Manufacturer Narrative

As reported, during a percutaneous transluminal angioplasty (pta)/femoral procedure, the 110 cm.6 fr.Mb pigtail 6sh catheter had broken in two parts: the distal part remained inside the patient but the staff was able to remove it with another device.Now both parts are available for further examination.The customer did not perform any kind of movement that could break in two the catheter and did not modify the device before the procedure.There was no reported patient injury.Additional information received indicated that the reported product issue of separation did not particularly occur during withdrawal of the product.There was more reported resistance than usual but no reported withdrawal difficulty or excessive force used during withdrawal.A guidewire was in place during withdrawal of the product as per the instructions for use (ifu).An embolic protection device was used to successfully retrieve the separated portion of the device.There was no reported difficulty advancing the product to the intended location.No target lesion/target lesion characteristic information was available.Another catheter was used to complete the procedure successfully with no patient injury.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu with no problems noted during preparation.There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.No additional information is available.One non-sterile unit of cath mb 5f pig 110cm 6sh was received coiled inside a plastic bag.Per visual analysis, the catheter was found separated in two sections that was received for analysis.The catheter body separation was found at 24.0cm from catheter distal end.No other issues were found.The catheter id/od were measured near to catheter body separated condition and the od was measured at different locations within the length of the complaint unit and results were found within specification.The insertion/withdrawal test could not be performed due to the separated condition or the received catheter.The catheter body separated areas were observed under the vision system and the separated edges presents elongation characteristics.The separated catheter body was sent to sem analysis with the following results: results showed that the catheter body separated sections presented with evidence of elongations.The elongations observed suggest that the device was induced to stretching/pulling events that exceed the material yield strength prior to the separation.No other issues were noted during sem analysis.  the complaint reported by the customer as ¿catheter (body/shaft) - withdrawal difficulty¿ and ¿catheter (body/shaft) - separated-in patient¿ was confirmed due to the condition in which the device was received.The cause of the event experienced by the customer could not be conclusively determined.However, procedural factors may have contributed to the reported event as evident by elongations which could be attributed to tensile forces.According to the products instructions for use, users are warned that manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.Neither the device history record review nor the product analysis suggests that the event is related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: karla castro ; 14201 nw 60th ave.; miami lakes, FL 33014
• MDR Report Key: 6560083
• MDR Text Key: 74937139
• Report Number: 9616099-2017-01086
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 17565293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/18/2017
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Life Threatening; Required Intervention