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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC; PROWLER SELECT PLUS
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CODMAN AND SHURTLEFF, INC; PROWLER SELECT PLUS Back to Search Results
Catalog Number UNK-CES MICROCATHETERS
Device Problems Premature Activation (1484); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2015
Event Type  malfunction  
Manufacturer Narrative
It was reported by the hospital contact that when inserting the complaint enterprise 2 (enc402300/10535381) into the prowler select plus microcatheter (lot unknown), the physician experienced a resistance at the distal point of the microcatheter and attempted to withdraw it.However, the vrd was deployed in the hub of the microcatheter during the withdrawal.Thus, the vrd was withdrawn together with the microcatheter.Instead, a balloon catheter (type unknown) was inserted and the aneurysm was embolized successfully.The procedure was completed without any delay, and there were no patient injury/complications.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.No visible damage was noted on the product prior to the event.The compliant product was already discarded.No further information is available.The procedure was the coil embolization of an internal carotid cerebral aneurysm (wide neck) at internal carotid artery.Based on the information, the event was not confirmed.The product was not returned for analysis; however procedural factors may have contributed to the event.The sterile lot was not provided therefore a review of the manufacturing documentation associated with this lot could not be performed.No corrective actions will be taken at this time.Concomitant medical products and therapy dates: enterprise 2 (enc402300/10535381).Balloon catheter (type unknown).This is an initial/final report.This is 1 of 2 reports associated with 1226348-2015-00058.
 
Event Description
It was reported by the hospital contact that when inserting the complaint enterprise 2 (enc402300/10535381) into the prowler select plus microcatheter (lot unknown), the physician experienced a resistance at the distal point of the microcatheter and attempted to withdraw it.However, the vrd was deployed in the hub of the microcatheter during the withdrawal.Thus, the vrd was withdrawn together with the microcatheter.Instead, a balloon catheter (type unknown) was inserted and the aneurysm was embolized successfully.The procedure was completed without any delay, and there were no patient injury/complications.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.No visible damage was noted on the product prior to the event.The compliant product was already discarded.No further information is available.The procedure was the coil embolization of an internal carotid cerebral aneurysm (wide neck) at internal carotid artery.
 
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Type of Device
PROWLER SELECT PLUS
Manufacturer (Section D)
CODMAN AND SHURTLEFF, INC
325 paramount dr
raynham MA
Manufacturer Contact
kimberly soter
325 paramount dr
raynham, MA 02767
5089777396
MDR Report Key5160343
MDR Text Key29216399
Report Number1226348-2015-00057
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 10/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK-CES MICROCATHETERS
Was Device Available for Evaluation? No
Date Manufacturer Received10/15/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Initial
Patient Sequence Number1
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