MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 5 FR 80CM; CATHETER, FLOW DIRECTED

Model Number IPN923529

Device Problem Leak/Splash (1354)

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

Event Date 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The report states "it was reported that the inflation test was done without problem.However, when the high pressure (520psi) was injected with an injector, the catheter got ruptured.Therefore, it was replaced with a new one.No harm to the patient was reported.According to the user, he/she had been able to use the same products without problem under the same condition until then." additional information states that the second catheter was inserted at the same insertion site.No additional medical intervention was required.

Event Description

The report states "it was reported that the inflation test was done without problem.However, when the high pressure (520psi) was injected with an injector, the catheter got ruptured.Therefore, it was replaced with a new one.No harm to the patient was reported.According to the user, he/she had been able to use the same products without problem under the same condition until then." additional information states that the second catheter was inserted at the same insertion site.No additional medical intervention was required.

Manufacturer Narrative

(b)(4).The reported lot number (16f22e0102) matches the lot number on the returned original packaging pouch/label.Returned for investigation was a 5fr.80cm berman catheter with the original packaging lid-stock.Upon return, the catheter body was immediately noted ruptured near the junction hub; the body was noted ruptured from approximately 86.6cm to 87cm from the distal tip of the catheter.The supplied control stroke syringe was noted connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned syringe.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 0.75cc.Upon microscopic inspection, the balloon appeared typical; some dried contrast media was noted on the balloon surface.No condensation was noted within the inflation lumen extension line.No contrast media was noted within the injection lumen extension line.The berman holes (injection lumen) near the catheter tip were noted blocked off by dried blood/contrast media.Dried blood was noted on the exterior of the sample.No other 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 a radius ratio less than or equal to 2.0.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.No pull away was noted after the tug test.The balloon was placed in water and air was injected into the inflation lumen again.No leak was noted.The damaged/ruptured catheter body did not result in damage to the inflation lumen.The catheter's injection lumen was aspirated/flushed, and air was noted leaking from the damaged/ruptured catheter body.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 catheter body ruptured in use is confirmed.The catheter body was found damaged/ruptured near the junction hub upon receipt of the sample.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 damaged/ruptured catheter body.The root cause of the damaged/ruptured catheter body is undetermined.

• Brand Name: CATH PKGD: BERMAN 5 FR 80CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16006294
• MDR Text Key: 308364037
• Report Number: 3010532612-2022-00564
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: IPN923529
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F22E0102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2022
• 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