MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: PACING 5 FR 110CM 25MM SPACIN

Catalog Number AI-07155

Device Problem Failure to Capture (1081)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported the catheter was inserted into the patient and no electrical pulse was generated.The user tried a new pacer wire and was successful.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).The product was not returned for investigation.The reported complaint of pacing catheter low/no signal 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 Description

It was reported the catheter was inserted into the patient and no electrical pulse was generated.The user tried a new pacer wire and was successful.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of pacing catheter low/no signal is not confirmed.The returned device passed functional test specifications.During functional testing, both the distal and proximal electrodes met product 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 revised risk.This will be monitored for any developing trends.

Event Description

It was reported the catheter was inserted into the patient and no electrical pulse was generated.The user tried a new pacer wire and was successful.There was no report of patient complications, serious injury or death.

• Brand Name: CATH PKGD: PACING 5 FR 110CM 25MM SPACIN
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kaylia pen ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 12202466
• MDR Text Key: 264948455
• Report Number: 3010532612-2021-00200
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: AI-07155
• Device Lot Number: 16F20J0125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 08/10/2021; 05/04/2022
• Supplement Dates FDA Received: 08/13/2021; 05/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NI.; NI.; NI.