MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI SET: 8 FR; INTRODUCER, CATHETER

Catalog Number SI-09808

Device Problems Bent (1059); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the device (guide wire) is bent in the sealed blister.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports the device (guide wire) is bent in the sealed blister.

Event Description

The customer reports the device (guide wire) is bent in the sealed blister.

Manufacturer Narrative

(b)(4).The customer returned a single guide wire for evaluation.The guide wire was returned within the advancer tube and showed no evidence of use.The guide wire was observed to have a single kink towards the distal end of the body.The distal j-bend was intact.Microscopic examination confirmed the kink in the guide wire body.Both welds were present and were observed to be full and spherical.The kink in the guide wire were located 16mm from the distal tip.The overall length and outer diameter of the guide wire were measured and were found to be within specification.The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.The report that the spring wire guide was found to be kinked prior to use was confirmed through visual examination of the returned sample.Visual examination revealed the guide wire was kinked towards the distal end of the body.The damage observed is consistent with damage occurring during transit.A device history record review was performed on the packaging, assembly and manufacturing of the guide wire with no relevant findings identified.Based on the sample received, it was determined that storage and shipping caused or contributed to this issue.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PSI SET: 8 FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7465349
• MDR Text Key: 106706538
• Report Number: 3006425876-2018-00256
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: SI-09808
• Device Lot Number: 71F17H1682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1