MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MULTI-LUMEN/PSI SET; INTERVENTIONAL PSI PRODUCTS

Catalog Number SI-11142

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The event was initially evaluated and determined to be non-reportable.The returned device was evaluated and the event was determined to be a result of a product malfunction, therefore it is reportable.

Event Description

It was reported that during insertion in ane, the md was unable to advance the guide wire through the ars.As a result, a new kit was opened and used without issue.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

(b)(4).Device evaluation: it was reported that the md was unable to advance the guide wire through the ars was confirmed.One opened si-11142 kit, containing a guide wire and numerous other components, was returned.The arrow raulerson syringe (ars) was not returned.The returned guide wire was observed to be kinked 2 cm from the j-tip.Microscopic evaluation also found an offset coil located 1 cm from the j-tip weld.Both welds were observed to be full and spherical.A manual tug test confirmed that both welds remain intact and the wire feels typical.The guide wire graphic specifies an outside diameter of.838/.877 mm and a length of 454 +/- 4 mm.The guide wire length was measured at 456 mm.The outside diameter measured.854 mm.Both measurements met specifications.The instructions booklet provided with the kit, describes suggested techniques to minimize the likelihood of guide wire damage during use.A device history record review was performed and did not reveal any manufacturing related issues.The probable cause of this issue could not be determined without a complete sample.No further action will be taken.

• Brand Name: MULTI-LUMEN/PSI SET
• Type of Device: INTERVENTIONAL PSI PRODUCTS
• 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: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 6132581
• MDR Text Key: 61035375
• Report Number: 3006425876-2016-00370
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K002507
• 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: 11/28/2016

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 Expiration Date: 03/31/2020
• Device Catalogue Number: SI-11142
• Device Lot Number: 71F15D0717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2015
• 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