MAUDE Adverse Event Report: DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0497

Device Problems Device Damaged Prior to Use (2284); Moisture or Humidity Problem (2986)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.We continue our efforts to follow up with the customer for its return.(b)(4).

Event Description

The mega 8 fr.50cc intra-aortic balloon's (iab) outer packaging was found wet upon delivery.The package was found in this manner prior to use.No patient involvement.

Manufacturer Narrative

Although good faith efforts have been attempted to retrieve the device, the device was not returned by the customer and so could not be evaluated.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.(b)(4).

Event Description

The mega 8 fr.50cc intra-aortic balloon's (iab) outer packaging was found wet upon delivery.The package was found in this manner prior to use.No patient involvement.

Manufacturer Narrative

(b)(4).Correction: the complaint could not be confirmed.The complaint was confirmed.(b)(4).No decontamination or visual inspection performed since product was not returned.A picture was provided which confirms the event of water damage, but we are unable to determine a root cause since the product was not returned and so could not be evaluated.A lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.The complaint could not be confirmed.Complaint # (b)(4).

Event Description

The mega 8 fr.50cc intra-aortic balloon's (iab) outer packaging was found wet upon delivery.The package was found in this manner prior to use.No patient involvement.

Manufacturer Narrative

(b)(4).

Event Description

The mega 8 fr.50cc intra-aortic balloon's (iab) outer packaging was found wet upon delivery.The package was found in this manner prior to use.No patient involvement.

Manufacturer Narrative

From: the mega catheter kit was returned intact and sealed.Visual examination was performed and no water damage was detected.The returned product was visually inspected and found to be within specification.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.To: the mega catheter kit was returned intact and sealed.Visual examination was performed and no water damage was detected.The returned product was visually inspected and there were no defects observed.An evaluation of the product was unable to duplicate the reported problem.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.(b)(4).

Event Description

The mega 8 fr.50cc intra-aortic balloon's (iab) outer packaging was found wet upon delivery.The package was found in this manner prior to use.No patient involvement.

Manufacturer Narrative

The mega catheter kit was returned intact and sealed.Visual examination was performed and no water damage was detected.The returned product was visually inspected and found to be within specification.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.(b)(4).

Event Description

The mega 8 fr.50cc intra-aortic balloon's (iab) outer packaging was found wet upon delivery.The package was found in this manner prior to use.No patient involvement.

• Brand Name: MEGA 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 6673632
• MDR Text Key: 78774979
• Report Number: 2248146-2017-00051
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/17/2020
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000045495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1