MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: PACING 5FR 110CM 25MM SPACING; CATHETER, ELECTRODE RECORDING, OR PR

Catalog Number AI-07155

Device Problem Material Separation (1562)

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

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that during use on a patient for temporary pacing, "the body of the catheter covering the electrical wire proximal to the hub of balloon inflation port was found to be separated and the wires inside was exposed.No compression or excessive external force was acted on the catheter to induce a possible damage according to the user.The exposed part was wrapped by tegaderm.The catheter was removed after the therapy entirely." no patient harm or injury.The patient status is reported as "fine".

Event Description

It was reported that during use on a patient for temporary pacing, "the body of the catheter covering the electrical wire proximal to the hub of balloon inflation port was found to be separated and the wires inside was exposed.No compression or excessive external force was acted on the catheter to induce a possible damage according to the user.The exposed part was wrapped by tegaderm.The catheter was removed after the therapy entirely." no patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The lot number (16f23c0060) 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.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 closed position.The recommended volume capacity of the balloon is 0.75cc.No condensation was noted in the inflation lumen extension line.Under microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon.The distal and proximal electrode appeared typical.The distal and proximal electrode extension leads appeared typical; no damage or abnormalities were noted.A clear medical tape was noted on the shrink tube assembly (connection point of the electrical extension tubing and distal/proximal electrode extension lines).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.The clear medical tape was removed from the shrink tube assembly and further inspection was performed.Upon removal of the clear medical tape, the electrical extension tubing was noted separated and no longer attached to the shrink tube assembly (connection point of the electrical extension tubing and distal/proximal electrode extension lines) and the distal/proximal electrode wires were noted exposed.Upon microscopic inspection , no damage was noted to the proximal end of the electrical extension tubing or to the interior surfaces of the shrink tube.No visual damage was noted to the distal/proximal electrode wires.The cause of the electrical extension tubing and shrink tube assembly separation could not be confidently determined.The customer provided a photo for review.The photo showed the electrical extension tubing was noted separated and no longer attached to the shrink tube assembly.This is consistent with the reported event.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 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.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 1.1 ohms and passed functional testing.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.Both distal and proximal electrodes were cross checked, and no short circuit was found.The catheter body separation did not cause any functional issue related to the electrical leads.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 that the "body of the catheter covering the electrical wire proximal to the hub of balloon inflation port was found to be separated and the wires inside was exposed" is confirmed.During the investigation, the returned electrical extension tubing was noted separated and no longer attached to the shrink tube assembly.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 catheter body separation from the shrink tube assembly.The root cause of the complaint is undetermined.The complaint finding is considered isolated.No further action required at this time.This will be monitored for any developing trends.

• Brand Name: CATH PKGD: PACING 5FR 110CM 25MM SPACING
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PR
• 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: 17586060
• MDR Text Key: 322371033
• Report Number: 3010532612-2023-00473
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AI-07155
• Device Lot Number: 16F23C0060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2023
• 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