MAUDE Adverse Event Report: CORDIS CORPORATION CATH MB 5F PIG 65CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 532598C

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2018

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 is available for evaluation and testing.However, the product has not been returned as of to date.Additional information will be submitted within 30 days upon receipt.

Event Description

The report received indicated that during an unknown procedure, the 65 cm.Super torque mb pigtail 8sh catheter was broken in two (2) parts inside the artery and/or catheter sheath introducer (csi).The physician successfully removed both parts of the catheter using a retriever catheter.There was no reported patient injury.

Manufacturer Narrative

During an unknown procedure, the 65 cm super torque mb pigtail 8sh catheter broke into two parts inside the artery and/or catheter sheath introducer (csi).The physician successfully removed both parts of the catheter using a retrieval catheter.There was no reported patient injury.Multiple attempts to obtain additional information were unsuccessful.The device was not returned for analysis.A product history record (phr) review of lot 17606614 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer as ¿catheter (body/shaft) separated - in-patient¿ could not be confirmed as the device was not returned for analysis.Based on the limited information available for review, vessel characteristics (while unknown) as well as procedural and handling factors may have contributed to the reported event.According to the instructions for use (ifu), which is not intended as a mitigation ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and gently withdraw the catheter.Prior to using the device, inspect for bends, kinks or other damage.To prevent kinking of the catheter, ensure that the pigtail catheter is not straightened by hand, but only with a diagnostic guidewire.Avoid excessive tension on the device during manipulation.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.¿ the phr does not suggest 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 65CM 8SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7608432
• MDR Text Key: 111303472
• Report Number: 9616099-2018-02193
• Device Sequence Number: 1
• Product Code: DQO
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 532598C
• Device Lot Number: 17606614
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/16/2018
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1