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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR/6 FR 2-L
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ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR/6 FR 2-L Back to Search Results
Catalog Number AI-07155-IK
Device Problem Application Program Version or Upgrade Problem (2881)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/23/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that when the catheter was inserted through the introducer, the doctor stated it felt as if it was "stuck".He removed the catheter and noted that it was kinked and twisted.As a result, a new catheter was used to complete the treatment at the same insertion site, as the introducer was still in the patient and 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 catheter kinked/bent 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 lot number reported on the complaint report does not exist for the reported material, therefore, a device history record (dhr) review was unable to be completed.A request for lot number clarification was submitted.Additionally, the lot number history for this account was unable to be retrieved.If any lot number information is available at a later date, the complaint will be updated accordingly.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
 
Event Description
It was reported that when the catheter was inserted through the introducer, the doctor stated it felt as if it was "stuck".He removed the catheter and noted that it was kinked and twisted.As a result, a new catheter was used to complete the treatment at the same insertion site, as the introducer was still in the patient and was used.There was no report of patient complications, serious injury or death.
 
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Brand Name
PACING/PSI KIT: 5 FR/6 FR 2-L
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10133149
MDR Text Key195098302
Report Number3010532612-2020-00146
Device Sequence Number1
Product Code LDF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAI-07155-IK
Device Lot Number73F19A0544
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age86 YR
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