MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET; CATHETER, INTRODUCER

Catalog Number CL-07645

Device Problems Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The preliminary evaluation of the returned device sample indicates the sheath tight over non-arrow catheter.The sheath appears to be undamaged but the bard catheter was kinked/deformed.

Event Description

The customer reports the saf sheath had a bard balloon stuck, and could not pull out balloon.Bard balloon damaged.

Event Description

The customer reports the saf sheath had a bard balloon stuck, and could not pull out balloon.Bard balloon damaged.

Manufacturer Narrative

(b)(4).The customer returned one sheath assembly and a bard balloon catheter for evaluation.Visual examination of the returned sheath revealed a small portion of the catheter was extruding through the distal tip.The returned catheter was torn and separated.The catheter contained multiple kinks.Much of the catheter appeared a lighter green, indicating excessive force.A portion of the catheter was pulled out of the sheath and fragments of the balloon were found.The length, outer diameter, and inner diameter of the returned sheath were measured and all were found to be within specification.The outer diameter of the returned bard catheter measured to be 1.665 mm.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user, "upon removal of sheath, inspect it to ensure entire length has been withdrawn." the reported complaint of sheath/catheter resistance was confirmed by complaint investigation.The returned bard catheter was broken and separated inside the returned sheath.Removal of the catheter from the sheath revealed fragments of balloon, indicating the catheter was pulled from the sheath while it was still inflated.The returned sheath passed all relevant dimensional testing.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.Based on the sample received, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET
• Type of Device: CATHETER, INTRODUCER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7370458
• MDR Text Key: 103525960
• Report Number: 9680794-2018-00068
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: CL-07645
• Device Lot Number: 14F17G0207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Date Manufacturer Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BARD BALLOON; BARD BALLOON
• Patient Age: 82 YR