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

Model Number	IPN000074
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported by (b)(6) lab at (b)(6) hospital.It was reported that balloon burst while in use.Three follow up attempts were made to obtain additional information regarding the patient condition and if the device is available for return but they were unsuccessful.If we received additional information, the complaint file will be updated.
Additional Manufacturer Narrative
Qn#(b)(4).The product was not returned for investigation.The reported complaint that the "balloon burst while in use" is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.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 by kenneth gaines supply coor caradic cath lab at texas childrens hospital.It was reported that balloon burst while in use.Three follow up attempts were made to obtain additional information regarding the patient condition and if the device is available for return but they were unsuccessful.If we received additional information, the complaint file will be updated.

• 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: 12129837
• Report Number: 3010532612-2021-00189
• Device Sequence Number: 4660474
• Product Code: DYG
• UDI-Device Identifier: 00801902002884
• UDI-Public: 00801902002884
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 07/31/2022
• Device Model Number: IPN000074
• Device Catalogue Number: AI-07127
• Device Lot Number: 16F21B0160
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1