MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI KIT: 8.5 FR X 10 CM; INTRODUCER, CATHETER

Catalog Number ASK-29804-UHN2

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges a small occlusion between the blue hub and catheter preventing the guidewire from passing through.

Manufacturer Narrative

(b)(4).The customer returned a spring-wire guide assembly (with guide wire retracted), a separate single guide wire and an introducer catheter (from catheter-over-needle subassembly) for evaluation.Each of the components showed evidence of use.The introducer catheter was visually examined and no defects or anomalies were observed.The guide wire that was returned retracted within the advancer assembly was observed to be kinked with offset coils in several locations towards the distal tip.The other guide wire was slightly deformed but no distinct kinks were observed.The introducer catheter inner diameter, the catheter outer diameter, and the overall length of the catheter were measured and found to be within specification.The outer diameter of the guide wires were also found to be within specification.The undamaged spring-wire guide was inserted into the catheter hub 4 times, rotating the catheter turn between insertions.Resistance was encountered during each of the insertions preventing the spring-wire guide from passing through the catheter.After functional testing, the hub of the catheter was cross-sectioned and microscopically examined.The hub was found to be de formed at the transition point.Other remarks: a device history record (dhr) review was performed on the introducer catheter and no relevant manufacturing issues were identified.The customer complaint of a blockage in the introducer catheter preventing the advancement of the guide wire was confirmed during sample investigation.During functional testing it was found that the spring-wire guide would not pass through the catheter at certain orientations.The introducer catheter was cross-sectioned and a molding issue was identified inside the hub.The probable cause of this issue is manufacturing related.The defect observed is consistent with defects documented in a previously opened capa, which has been initiated to further investigate this issue.The capa corrective actions have not yet been implemented.

Event Description

The customer alleges a small occlusion between the blue hub and catheter preventing the guidewire from passing through.

• Brand Name: ARROW PSI KIT: 8.5 FR X 10 CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6842836
• MDR Text Key: 84939689
• Report Number: 3003737899-2017-00102
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K940079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

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: No Information
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: ASK-29804-UHN2
• Device Lot Number: 13F17F0723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/05/2017
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2017
• 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