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

Catalog Number SI-09808

Device Problems Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the tip of the spring wire guide (swg) was kinked.The alleged issue was detected when the kit was opened.A new kit was used without issue.

Manufacturer Narrative

(b)(4).Conclusions - complaint confirmed.No code available.Probable cause is shipping and handling.Visual examination of the returned, un-used sample revealed the guide wire body is kinked towards the distal end at the j-bend.The guide wire returned advanced within the advancer tube and straightener.Microscopic examination confirmed the kink and identified offset coils at the kink location.No other damage to the components was observed.Both guide wire welds were full and spherical.The kink in the guide wire was located 1.5cm (ruler: (b)(4)) from the distal tip.The overall length of the guide wire measured 455 mm which is within the specification of 450-458mm per guide wire drawing.The outside diameter of the guide wire measured 0.854mm (micrometer: (b)(4)) which is within the specification.The inner diameter of the tip of the straightener tube measured 0.038" (pin gauges: (b)(4)) which is within the specification.Resistance was met when attempting to advance the kinked section of the guide wire through the straightener tube.A manual tug test confirmed both the proximal and distal welds were intact.Other remarks: it is determined that neither packaging design nor the packaging process is the likely root cause for this reported issue, while shipping could have caused the defects reported.A device history record review was performed on the guide wire assembly and no relevant issues were identified.The complaint was confirmed.No further action will be taken.

Event Description

The customer reports that the tip of the spring wire guide (swg) was kinked.The alleged issue was detected when the kit was opened.A new kit was used without issue.

• Brand Name: ARROW PSI SET: 8 FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 6587757
• MDR Text Key: 75857280
• Report Number: 3006425876-2017-00166
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K780532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: SI-09808
• Device Lot Number: 71F16E1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2016
• 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