MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 4 FR 60CM; CATHETER, FLOW DIRECTED

Model Number	IPN000067
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that the balloon did not inflate evenly after placement of the catheter to a pediatric patient.Therefore, it was removed and replaced with a new kit.It was unknown if the user did an inflation test before use.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
Qn#: (b)(4).Teleflex received the device for investigation.The reported complaint of balloon asymmetrical is confirmed; however, the balloon met dimensional specifications.The returned device passed functional and dimensional testing.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 revised risk.This will be monitored for any developing trends.
Event or Problem Description
It was reported that the balloon did not inflate evenly after placement of the catheter to a pediatric patient.Therefore, it was removed and replaced with a new kit.It was unknown if the user did an inflation test before use.There was no report of patient complications, serious injury or death.

• Brand Name: CATH PKGD: WEDGE 4 FR 60CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12049014
• Report Number: 3010532612-2021-00165
• Device Sequence Number: 4411744
• Product Code: DYG
• UDI-Device Identifier: 00801902002822
• UDI-Public: 00801902002822
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 12/31/2021
• Device Model Number: IPN000067
• Device Catalogue Number: AI-07121
• Device Lot Number: 16F20H0085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1