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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 5 FR 80CM; CATHETER, FLOW DIRECTED
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ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 5 FR 80CM; CATHETER, FLOW DIRECTED Back to Search Results
Model Number IPN917235
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that "the catheter got torn during the procedure.Therefore, it was replaced with a new one, inserted at the same insertion site to complete the procedure.No harm to the patient".The patient status is reported as fine.
 
Manufacturer Narrative
Qn#(b)(4).The reported complaint that the "catheter got torn during the procedure" was confirmed based upon the sample received.The customer returned a 5fr.80cm berman catheter without the original packaging (inp-4) for investigation.The sample was returned in the ups shipping box and was in a sealed ziploc bag (inp-1, inp-2).Upon return, the catheter body was immediately noted ruptured near the junction hub; the body was noted ruptured from approximately 88.2cm to 88.7cm from the distal tip of the catheter (inp-8, inp-9).The inflation lumen stopcock was in the open position (inp-5).The recommended volume capacity of the balloon was 0.75cc (inp-6).The supplied control stroke syringe was not returned with the sample.Upon microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon (inp-7).No condensation was noted within the inflation lumen extension line.Some spots of dried contrast media were noted within the injection lumen extension line.Spots of dried blood/contrast media were noted on the exterior surfaces of the returned sample.No other 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 (anp-1, anp-2).Both the sides of the balloon measured approximately 4mm each.The balloon did meet specifications per graphic of radius ratio less than or equal to 2.0.The inflation lumen was injected with 0.75cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically (anp-1, anp-2) and then deflated in less than 3 seconds when the syringe was removed per specification.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 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 ruptured catheter body (anp-3).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.However, the specifications were not met during the complaint investigation due to the ruptured catheter body.The probable root cause of the complaint was manufacturing related.A capa has been initiated under teleflex's quality system by the manufacturing site to further address this complaint issue.
 
Event Description
It was reported that "the catheter got torn during the procedure.Therefore, it was replaced with a new one, inserted at the same insertion site to complete the procedure.No harm to the patient".The patient status is reported as "fine".
 
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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
kevin don bosco
3015 carrington mill blvd
morrisville 27560
MDR Report Key17152691
MDR Text Key318091939
Report Number3010532612-2023-00331
Device Sequence Number1
Product Code DYG
UDI-Device Identifier10801902180787
UDI-Public10801902180787
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K892530
Number of Events Reported1
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 05/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2024
Device Model NumberIPN917235
Device Catalogue NumberAI-07135
Device Lot Number16F22L0062
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received07/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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