MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI SET: 8.5 FR; INTRODUCER, CATHETER

Catalog Number SI-09880

Device Problem Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The preliminary evaluation of the returned device sample indicates the swg kinked in package.

Event Description

The customer reports the swg (spring wire guide) was found unraveled when opening the package.

Event Description

The customer reports the swg (spring wire guide) was found unraveled when opening the package.

Manufacturer Narrative

(b)(4).The customer returned an opened si-09880 kit containing a kinked guidewire and some additional components.The guidewire was inside the advance tube but out of the guard.The distal end was found to be kinked with several instances of coil offset near at the j-tip.No signs of use were identified.The tray was found to be damaged and was no longer able to lay flat.No issues were identified with the other components.Due to the tray also being damaged, but not noted by the customer, it cannot be determined when this issue occurred.The length and outer diameter of the guidewire were measured and were found to be within specification.A manual tug test was performed on both welds to confirm they were still intact.The customer reported issue of the guidewire being found unraveled in the kit was not confirmed, however a kinked guidewire was returned.Visual inspection was performed on the returned guidewire and it was found to be kinked at the distal end with several instances of coil offset.The tray the guidewire was returned in was also damaged.Dimensional inspection was performed on the guidewire and no issues were identified.Based on the information and sample provided the probable cause of this issue could not be determined.

• Brand Name: ARROW PSI SET: 8.5 FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7326794
• MDR Text Key: 102099029
• Report Number: 3006425876-2018-00163
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K780532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SI-09880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 04/13/2018
• Supplement Dates FDA Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1