MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: PACING 5FR 105CM 15MM SPACING; CATHETER, ELECTRODE RECORDING

Model Number IPN000093

Device Problem Failure to Sense (1559)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

The report states "balloon catheter placed in patient and unable to capture despite multiple attempts".As a result, "a new device was used to complete the procedure".No patient harm or injury.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).The lot number (16f22m0015) recorded on the complaint report matches the lot number on the returned original packaging lid-stock/label.Returned for investigation was a 5 fr.Bi-polar pacing catheter with the original packaging lid-stock.The sample was returned in the cardboard box and was in a sealed ziploc bag.Upon return, the supplied control syringe was connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned control stroke syringe.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 0.75cc.No condensation was noted in the inflation lumen.Under microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon.The distal and proximal electrode appeared typical.A non-teleflex cable connector was noted connected to the distal and proximal electrode extension leads.Upon disconnecting the electrode extension leads, the distal and proximal electrode extension leads appeared typical; no damage or abnormalities were noted.Spots of dried blood were noted on the exterior surfaces of the returned sample.No blood was noted on the interior surfaces of the returned sample.No visual damage or abnormalities were noted.The inflation lumen was injected with 0.75cc of air using the returned control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 4mm.The other side measured approximately 4mm.The balloon did meet specifications per graphic i-07154-007 rev.7 of radius ratio less than or equal to 1.5.The inflation lumen was injected with 0.75cc of air using the returned control stroke syringe.The balloon inflated symmetrically.The balloon deflated in less than 3 seconds when the syringe was removed per specification i-07154-00 rev.7.Upon tug test, no pull away was noted.The balloon was placed in water, and air was injected into the inflation lumen again.No leak was noted.The distal electrode and distal extension lead (white wire) were connected to a multi-meter and continuity was found between the leads.The resistance measured 1.2 ohms and passed functional testing per i-07154-007 rev.7.The proximal electrode and proximal extension lead (blue wire) were connected to a multi-meter and continuity was found between the leads.The resistance measured 1.3 ohms and passed functional testing per i-07154-007 rev.7.The distal and proximal electrodes/extension leads were cross connected to a multimeter, and continuity was present between both the distal and the proximal electrode.This is consistent with a cross-connection between the electrodes and does not meet specifications.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.The reported complaint of pacing catheter low/no signal is confirmed.Upon function testing, continuity was present while the distal and the proximal electrodes were cross connected.This is consistent with a cross connection between the electrodes, which caused the complaint.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the cross-connection between the electrodes.The most probable root cause is manufacturing related.A non-conformance has been initiated to further investigate the issue.Other remarks: n/a.Corrected data: n/a.

Event Description

The report states "balloon catheter placed in patient and unable to capture despite multiple attempts".As a result, "a new device was used to complete the procedure".No patient harm or injury.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: CATH PKGD: PACING 5FR 105CM 15MM SPACING
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17317050
• MDR Text Key: 319374989
• Report Number: 3010532612-2023-00383
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 00801902004512
• UDI-Public: 00801902004512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

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: 05/31/2024
• Device Model Number: IPN000093
• Device Catalogue Number: AI-07154-S
• Device Lot Number: 16F22M0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2022
• 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