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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FIBER OPTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problem Material Rupture (1546)
Patient Problems Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199)
Event Date 08/26/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The sales representative was proctoring in the cath lab. The event involved a (b)(6) in height patient. The intra-aortic balloon catheter (iab) was prepped and inserted via the patient's right femoral artery via a sheath. The fos was not inserted in the iabp prior to insertion and as a result the fos was inserted post insertion of the iab. At that time it was not recognized. The iab was used via the transducer. About 1 hour after the sales rep. Had left for the day he received a phone call on his cell from the clinical coordinator stating that the patient was moved to the icu and it appeared the balloon ruptured. As a result, the iab was removed. The patient did not receive another iab. There was no reported patient death, injury or complications. There was no reported medical or surgical intervention required. The patient outcome is okay. The clinical coordinator stated that they would keep the iab and do their own analysis and contact the sales rep. If the iab is available afterwards. The intra-aortic balloon pump (iabp) used in this case was s/n (b)(4).
 
Manufacturer Narrative
(b)(4). The product was not 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 the helium pathway is not able to be confirmed. No product was returned for evaluation. The root cause of the complaint is undetermined.
 
Event Description
The sales representative was proctoring in the cath lab. The event involved a 5'9" in height patient. The intra-aortic balloon catheter (iab) was prepped and inserted via the patient's right femoral artery via a sheath. The fos was not inserted in the iabp prior to insertion and as a result the fos was inserted post insertion of the iab. At that time it was not recognized. The iab was used via the transducer. About 1 hour after the sales rep. Had left for the day he received a phone call on his cell from the clinical coordinator stating that the patient was moved to the icu and it appeared the balloon ruptured. As a result, the iab was removed. The patient did not receive another iab. There was no reported patient death, injury or complications. There was no reported medical or surgical intervention required. The patient outcome is okay. The clinical coordinator stated that they would keep the iab and do their own analysis and contact the sales rep. If the iab is available afterwards. The intra-aortic balloon pump (iabp) used in this case was s/n (b)(4).
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
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 Key5967538
MDR Text Key55313619
Report Number1219856-2016-00205
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
Report Date 08/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem 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 Received10/12/2016
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

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