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

Model Number 532598B

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.It is unknown if the device will be returned for testing and evaluation.   additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 5f 110cm 6 side holes (sh) angiographic super torque pigtail marker band (mb) catheter ruptured completely during the change on a non-cordis 0.35 guide wire.A lasso recovery was performed.There was no reported patient injury.The device is expected to be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the 5f 110cm 6 side holes (sh) angiographic super torque pigtail marker band (mb) catheter ruptured completely during the change on a non-cordis 0.35 guide wire.A lasso recovery was performed.There was no reported patient injury.Additional procedural details were requested but not provided.The device was not returned for analysis.A product history record (phr) review of lot 17940006 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device for analysis, the reported customer event ¿catheter (body/shaft)- burst¿ could not be confirmed and the exact root cause could not be determined.Procedural/handling factors may have contributed to the reported event.Per the instructions for use, which is not intended as a mitigation of risk, ¿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.Extreme care to avoid stretching or elongation must be exercised during manipulation and withdrawal.If resistance is felt during manipulation, determine the cause of resistance before proceeding and confirm super torque® mb angiographic catheter positioning under high quality fluoroscopic observation.Do not advance or withdraw the super torque® mb angiographic catheter within the vascular system unless it is preceded by a guide wire.Exercise care when removing guidewires from multiple-curve catheters.Avoid excessive tension on the device during manipulation.¿ neither the phr review nor the information available suggests that the reported failure could be related to the manufacturing process of the unit.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 CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10465029
• MDR Text Key: 204703840
• Report Number: 9616099-2020-03871
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032012031
• UDI-Public: 20705032012031
• Combination Product (y/n): N
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 17940006
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LUNDERQUIST 0.35 COOK; LUNDERQUIST 0.35 COOK