MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR 2-L; CATHETER, ELECTRODE RECORDING

Catalog Number	AI-07155-KS
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
There was no patient involvement.Complaint was reported via email that one of the cardiology fellows sustained a puncture from scalpel #11 that is provided in the temporary pacing catheter with shrouded pins/introducer kit.Dr.Chen explained that most kits contain a sponge that is used to place sharps during emergent procedures.This sponge serves as a temporary sharp's disposal.This particular kit does not include this item.
Event or Problem Description
There was no patient involvement.Complaint was reported via email that one of the cardiology fellows sustained a puncture from scalpel #11 that is provided in the temporary pacing catheter with shrouded pins/introducer kit.Dr.Chen explained that most kits contain a sponge that is used to place sharps during emergent procedures.This sponge serves as a temporary sharp's disposal.This particular kit does not include this item.
Additional Manufacturer Narrative
Qn# (b)(4).The product was not returned for investigation.The complaint was reported as "cardiology fellows sustained a puncture from scalpel".The complaint is not able to be confirmed.The root cause of the complaint is undetermined.The complaint is considered isolated.The lot number for the complaint was not reported initially.A photo of an original packaging label was submitted with the complaint and a lot number was identified.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.

• Brand Name: PACING/PSI KIT: 5 FR 2-L
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12338213
• Report Number: 3010532612-2021-00249
• Device Sequence Number: 11663320
• Product Code: DRF
• UDI-Device Identifier: 30801902004537
• UDI-Public: 30801902004537
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K945229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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 Catalogue Number: AI-07155-KS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.