MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 7 FR 110 CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07127
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the spring wire guide was unable to advance thru the catheter.As a result, another catheter was used.There was a report of delay in therapy.There was no report of patient complication or serious injury and death.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of "unable to advance the wire through the catheter" is not confirmed.Upon functional testing, the guidewire was able to advance through the injection lumen without any difficulty.Although, the root cause of the complaint is undetermined the returned device passed visual and functional test specifications.No further action required at this time.
Event or Problem Description
It was reported that the spring wire guide was unable to advance thru the catheter.As a result, another catheter was used.There was a report of delay in therapy.There was no report of patient complication or serious injury and death.

• Brand Name: CATH PKGD: WEDGE 7 FR 110 CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8386835
• Report Number: 3010532612-2019-00043
• Device Sequence Number: 11211448
• Product Code: DYG
• UDI-Device Identifier: 00801902002884
• UDI-Public: 00801902002884
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: AI-07127
• Device Lot Number: 16F18K0086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 04/03/2019
• Patient Sequence Number: 1