MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: PACING 6 FR 110 CM; BIPOLAR ELECTRODE CATHETER

Catalog Number AI-06210

Device Problem Pacing Problem (1439)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the doctor proceeds to pass the pacemaker into the patient, it was noted that the lead does not stimulate.As a result, the electrode was exchanged.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of pacing catheter low/no signal is not able to be confirmed.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 risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that when the doctor proceeds to pass the pacemaker into the patient, it was noted that the lead does not stimulate.As a result, the electrode was exchanged.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

• Brand Name: CATH PKGD: PACING 6 FR 110 CM
• Type of Device: BIPOLAR ELECTRODE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9298288
• MDR Text Key: 183742337
• Report Number: 3010532612-2019-00400
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: AI-06210
• Device Lot Number: 16F18M0065
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.
• Patient Age: 64 YR
• Patient Weight: 57