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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-S840C
Device Problem Material Split, Cut or Torn (4008)
Patient Problems Death (1802); Pulmonary Edema (2020); No Consequences Or Impact To Patient (2199)
Event Date 03/29/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient attended with acute pulmonary edema and decongestant measures were performed with good results.Changes were observed in cardiac enzymes and the patient underwent cardiac catheterization, where diffuse and severe atherosclerotic disease was evidenced.When the intra-aortic balloon (iab) was used for myocardial revascularization surgery, it was noted that during insertion the iab was damaged.As a result, the iab was exchanged.There was a report of patient death.Doctor (b)(6) confirmed the device did not contribute to patient death.Additional information received from the distributor that the alleged event involved the guidewire that broke by inserting the catheter.
 
Manufacturer Narrative
(b)(4).No iab parts was returned to teleflex chelmsford for investigation.The reported complaint of iab swg insertion difficulty is not able to be confirmed.The root cause of the complaint is undetermined.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.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 the patient attended with acute pulmonary edema and decongestant measures were performed with good results.Changes were observed in cardiac enzymes and the patient underwent cardiac catheterization, where diffuse and severe atherosclerotic disease was evidenced.When the intra-aortic balloon (iab) was used for myocardial revascularization surgery, it was noted that during insertion the iab was damaged.As a result, the iab was exchanged.There was a report of patient death.Doctor (b)(6) confirmed the device did not contribute to patient death.Additional information received from the distributor that the alleged event involved the guidewire that broke by inserting the catheter.
 
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Brand Name
REDIGUARD IAB: 8FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8794740
MDR Text Key151188552
Report Number3010532612-2019-00242
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 06/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2020
Device Catalogue NumberIAB-S840C
Device Lot Number18F18D0041
Was Device Available for Evaluation? No
Date Manufacturer Received08/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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