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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CARDIAC UNKNOWN MATERIAL INTRA- AORTIC BALLOON FIBER OPTIC

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ARROW INTERNATIONAL INC. CARDIAC UNKNOWN MATERIAL INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problems Fluid Leak (1250); Leak/Splash (1354); Difficult to Remove (1528)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Respiratory Distress (2045)
Event Date 07/11/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). Sample not returned for investigation.
 
Event Description
It was reported via a phone call from the sales rep that he received a call from the customer stating there was an issue with a product. The intra-aortic balloon pump (iabp) team member did not give the sales rep information. On 07/26/2016 additional information received: it was stated to the clinical support specialist that the patient expired. There is no information about the event or the product number in use at this time. According to the information received by the sales rep. The iab balloon ruptured in use.
 
Manufacturer Narrative
Concomitant medical products: and resuscitation measures. Tissue plasminogen activator (tpa)(b)(4). Additional information was added to age/date of birth, weight, sex, outcomes attributed to adverse events, relevant tests/lab data, other relevant history, concomitant medical products and therapy dates, model/lot #, pma#, event problem codes, report source. On 8/15/2016 the medwatch report was received. The patient underwent cardiac catheterization and had an intra-aortic balloon pump (iabp) inserted via the right femoral artery. Approximately 4 hours after insertion, the ccu nurse noted flecks of blood in the iabp tubing indication balloon rupture. Helium was purged and the tubing was clamped. Attempts were made at the bedside to remove the catheter but resistance was encountered and the attempts were immediately stopped. Vascular surgery was consulted and the patient was taken to the operating room for a right groin exploration, removal of iabp, repair of right external iliac artery. At the time of the rupture of the iab, the patient began to experience cardiac and pulmonary decompensation. He was brought emergently to the or where he coded twice prior to the beginning of the case but was successfully resuscitated. The iab was found to be impacted in the distal aorta. Tpa was instilled into the balloon to soften the thrombus present. Surgical removal was initiated. The catheter was successfully removed and repair was completed. Other remarks: the patient coded at the end of the case as the skin was being closed and at the request of the family, no further resuscitation efforts were initiated.
 
Event Description
It was reported via a phone call from the sales rep that he received a call from the customer stating there was an issue with a product. The intra-aortic balloon pump (iabp) team member did not give the sales rep information. On 07/26/2016 additional information received: it was stated to the clinical support specialist that the patient expired. There is no information about the event or the product number in use at this time. According to the information received by the sales rep. The iab balloon ruptured in use.
 
Manufacturer Narrative
Concomitant medical products: and resuscitation measures. Tissue plasminogen activator (tpa) (b)(4). No product was returned for evaluation. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. Conclusion: the reported complaint of blood in helium pathway is not able to be confirmed. No product was returned for evaluation. The root cause of the complaint is undetermined. If the sample is returned at a later date, a full investigation will be completed.
 
Event Description
It was reported via a phone call from the sales rep that he received a call from the customer stating there was an issue with a product. The intra-aortic balloon pump (iabp) team member did not give the sales rep information. On 07/26/2016 additional information received: it was stated to the clinical support specialist that the patient expired. There is no information about the event or the product number in use at this time. According to the information received by the sales rep. The iab balloon ruptured in use.
 
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Brand NameCARDIAC UNKNOWN MATERIAL
Type of DeviceINTRA- AORTIC BALLOON FIBER OPTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key5845484
MDR Text Key51108878
Report Number1219856-2016-00174
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F16F0027
Other Device ID Number00801902007247
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/03/2016 Patient Sequence Number: 1
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