MAUDE Adverse Event Report: SURGE CARDIOVASCULAR SURGE CARDIOVASCULAR RETROGRADE MANUAL INFLATE, SMOOTH BALLOON

Model Number RMG-0015S

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Information (3190)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

The device will be returned for evaluation and will utilize the evaluation to confirm the complaint.

Event Description

Product seems to have changed from a soft to a rigid insertion.

Manufacturer Narrative

The device will be returned for evaluation and will utilize the evaluation to confirm the complaint.Corrected data: complaint was categorized as a malfunction but upon further investigation it should have been classified as a serious injury due to confirmation from the hospital that the coronary sinus was perforated and repaired during serious.Follow up: on july 3, 2018, surge cardiovascular received the lot number from the hospital relating to their complaint and the hospital confirmed that the coronary sinus was perforated during the surgery and repaired without further incident or delay.On july 5, 2018, surge cardiovascular submitted mdr form 3500a, mfr report number 3004963960-2018-00004 to the fda to report the incident.Surge cardiovascular continued its investigation into the root cause and scope of the product involved.With the lot information, surge was able to determine that only one lot was affected by the issue.On july 5, 2018 the hospital confirmed that the affected lot was quarantined at the hospital pending a distribution center check.Over the course of our investigation and at the request of the hospital, surge issued a return material authorization (rma) to the hospital to facilitate the return of the affected devices.The hospital also requested replacement product which was provided.On july 11, 2018, the hospital confirmed that no remaining product was at the distribution center.The entirety of the lot in question had been shipped to this one hospital and all remaining product was quarantined and presented no risk of being used during surgery.On july 16, 2018, the product was returned to surge cardiovascular and complaint was confirmed (device evaluation).At the same time, surge understood this action constituted a removal action.According to cfr 21 part 806 "medical devices; reports of corrections and removals," subpart b 806.10 (f), and in accordance with "medical device reporting for manufacturers guidance for industry and food and drug administration staff document issued on: november 8, 2016" this information was submitted on 18jul2018 on the follow up mdr.Further information: reason for the removal and the date and circumstances under which the product deficiency or possible deficiency was discovered: the customer complaint was received on june 15, 2018 and when the lot number was provided on july 3, 2018 through a review of device history records, we discovered that the device was built with a rigid style stylet instead of a flexible stylet therefore the product was mis-labeled.Evaluation of the risk associated with the deficiency or possible deficiency: a health hazard analysis was initiated on july 9 (b)(4) and the risk associated with this failure potential perforation of the coronary sinus, which is considered serious within the risk management file.This is inherent on every insertion due to the nature of insertion and the location requiring the surgeon to use caution on insertion.Total amount of such products produced and/or the time span of the production.There was (b)(4).Total amount of such products estimated to be in distribution channels.No product remains in distribution channels.All 7 boxes were purchased by one customer.All product in question was either previously used by the hospital without incident or returned for replacement product.Subject of customer complaint.Previously used by hospital without reported incident.Returned via rma.Distribution information, including the number of direct accounts and, where necessary, the identity of the direct accounts.One hospital was the only account impacted: (b)(6).All 7 boxes were purchased on april 20, 2018.Proposed strategy for conducting the recall.All product has been removed via rma and replaced through the customer complaint process.Name and telephone number of the firm official who should be contacted concerning the removal.(b)(4).The removal is complete and no further action is required relating to removing the product from market.

Event Description

Product seems to have changed from a soft to a rigid insertion.

• Brand Name: SURGE CARDIOVASCULAR RETROGRADE MANUAL INFLATE, SMOOTH BALLOON
• Type of Device: RETROGRADE MANUAL INFLATE
• Manufacturer (Section D): SURGE CARDIOVASCULAR; 2680 walker ave nw, suite c; walker MI 49544
• Manufacturer (Section G): SURGE CARDIOVASCULAR; 2680 walker ave nw, suite c; walker MI 49544
• Manufacturer Contact: kelli jonas ; 2680 walker ave nw, suite c; walker, MI 49544 ; 6162026120
• MDR Report Key: 7663611
• MDR Text Key: 113626450
• Report Number: 3004986960-2018-00004
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00817278010453
• UDI-Public: 00817278010453
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/01/2022
• Device Model Number: RMG-0015S
• Device Catalogue Number: RMG-0015S
• Device Lot Number: 00794-030718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 06/15/2018
• Supplement Dates FDA Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other