MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 6 FR 90 CM; CATHETER, FLOW DIRECTED

Model Number	IPN000073
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the balloon tip of the catheter is twisted.The device is placed at the jugularis and used for ballooning of the vessel for dogs (veterinary use).When the balloon tip is twisted it is very difficult to move the catheter in the vessel causing a delay resulting in an extension of the anesthesia." there was no report of harm or complications to the patient.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint that the "balloon tip of the catheter is twisted" is not able to be confirmed.A representative device was received for investigation with no damage or abnormalities noted.The balloon inflated as per specifications during the functional investigation.The returned device passed visual and functional test specifications.The root cause of the complaint is undetermined.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 revived risk.This will be monitored for any developing trends.
Event or Problem Description
It was reported that "the balloon tip of the catheter is twisted.The device is placed at the jugularis and used for ballooning of the vessel for dogs (veterinary use).When the balloon tip is twisted it is very difficult to move the catheter in the vessel causing a delay resulting in an extension of the anesthesia." there was no report of harm or complications to the patient.

• Brand Name: CATH PKGD: WEDGE 6 FR 90 CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9889591
• Report Number: 3010532612-2020-00101
• Device Sequence Number: 11282091
• Product Code: DYG
• UDI-Device Identifier: 00801902004468
• UDI-Public: 00801902004468
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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: 10/31/2020
• Device Model Number: IPN000073
• Device Catalogue Number: AI-07126-J
• Device Lot Number: 16F19F0100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1