MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. 6 FR 110 CM BALLOON WEDGE PRESSURE CATHETER; CATHETER, FLOW DIRECTED

Model Number	IPN000072
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "guide wire cannot be inserted into the catheter.".
Additional Manufacturer Narrative
Qn#(b)(4).Teleflex received the device for investigation.The reported complaint that the "guide wire cannot be inserted into the catheter" is confirmed.Upon visual inspection, the catheter body was noted with a flattened surface.Upon inserting a guidewire through the catheter, resistance was experienced at the location of the flattened surface noted on the catheter body.The root cause of the damaged/flattened catheter body is undetermined.A potential cause is customer handling.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
Event or Problem Description
It was reported that "guide wire cannot be inserted into the catheter.".

• Brand Name: 6 FR 110 CM BALLOON WEDGE PRESSURE CATHETER
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12165423
• Report Number: 3010532612-2021-00214
• Device Sequence Number: 1533473
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: 00801902002877
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 05/31/2022
• Device Model Number: IPN000072
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F20M0112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1