MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR/6 FR 2-L; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number AI-07155-IK

Device Problem Inflation Problem (1310)

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

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the balloon would not inflate when dr.(b)(6) was trying to float it in.He states it did inflate when he tested it first off.As a result, a new kit was used.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn# (b)(4).The product was not returned for investigation.The reported complaint of balloon would not inflate in use 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.The specific lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed 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 that the balloon would not inflate when dr (b)(6) was trying to float it in.He states it did inflate when he tested it first off.As a result, a new kit was used.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No lot number was reported.The lot number of the returned device is unknown.Returned for investigation was a 5fr.Bi-polar pacing catheter without original packaging.The sample was returned in the supplied return kit and was in a sealed bio-hazard bag.Upon return, the inflation lumen stopcock was in the closed position.The supplied control stroke syringe was not returned with the sample.The recommended volume capacity of the balloon is 0.75cc.Under microscopic inspection, a wrinkle was noted on the balloon surface; no other damage or abnormalities were noted to the balloon.No condensation was noted in the inflation lumen.The cath-guard was noted on the returned sample.The distal and proximal electrode appeared typical.The distal and proximal electrode extension leads appeared typical.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 a lab inventory 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 of radius ratio less than or equal to 1.5.The inflation lumen was injected with 0.75cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically.The balloon deflated in less than 3 seconds when the syringe was removed.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 specific lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.The risk of the reported event is acceptable.The returned device passed visual and functional testing.The reported complaint of balloon would not inflate in use is not confirmed.No damage or abnormalities were noted to the returned sample upon receipt.The balloon inflated as per specifications during the investigation, and the returned device passed visual and functional test specifications.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.

Event Description

It was reported that the balloon would not inflate when dr.Abonowara was trying to float it in.He states it did inflate when he tested it first off.As a result, a new kit was used.There was no report of patient complications, serious injury or death.

• Brand Name: PACING/PSI KIT: 5 FR/6 FR 2-L
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville, MA 27560
• MDR Report Key: 12422115
• MDR Text Key: 271251798
• Report Number: 3010532612-2021-00260
• Device Sequence Number: 1
• Product Code: LDF
• 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: 08/04/2021

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 Catalogue Number: AI-07155-IK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 09/22/2021; 11/17/2022
• Supplement Dates FDA Received: 09/23/2021; 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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